BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM QUICK SET MMT-397

    MDR report key: 7194362 · Received January 16, 2018

    Report

    Report Number
    2032227-2018-00662
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    February 1, 2016
    Report Date
    January 16, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    UDI-DI
    20643169442911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A NO DELIVERY ALARM THAT WAS RESOLVED BY CHANGING THEIR INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 108 MG/DL. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT DURING THE CALL. THE INFUSION SET IS EXPECTED TO BE RETURNED. (B)(6) 2016 14:51:24 PST CRM RFC USER (CRM_RFC_USER) COMPLAINTS TEXT (B)(6) 2016 16:48:28 (B)(6) INITIAL NOTES: CUSTOMER CALLED ABOUT THE INFUSION SETS LAST WEEK HE HAD ONE FULL EVERYTHING WAS FINE HE CHANGE OUT EVERYTHING THREE IN A ROLL GAVE HIM A NO DELIVERY THEY WERE AND HE HAS NEVER HAD THREE IN ONE BOX INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER WENT TO CHANGE OUT HIS SET YESTERDAY WHEN HE WEN THROUGH THREE SETS THAT GAVE HIM THE NO DELIVERY CUSTOMER INDICATES SERIOUS INJURY/HOSPITALIZATION: NO. DELIVERY ALARM T/S PER (B)(4). PATIENT'S BG AT TIME OF INCIDENT: 108 MG/DL. EXPL NO DELIVERY ALARM AND POSSIBLE CAUSES. CUSTOMER REPORTS THE ALARM WAS RESOLVED BY AN INFUSION SET CHANGE. ADV TO DO A COMPLETE SET CHANGE AS SOON AS POSSIBLE. CUSTOMER WOULD LIKE TO RETURN THE SET FOR ANALYSIS. CUSTOMER DOES NOT WANT TO RETURN THE RESERVOIR FOR ANALYSIS. CUSTOMER STATED THAT HE WENT THROUGH THREE SETS BUT ONLY SAVED TWO OF THEM MMT-397 LOT 5108174 CUSTOMER REPORTS THE ALARM OCCURRED DURING MANUAL PRIME. CUSTOMER IS NOT ABLE TO TROUBLESHOOT AT TIME OF CALL. UNABLE TO DETERMINE THE CAUSE OF THE ISSUE. RETURNING PRODUCT BASED ON CUSTOMER'S REQUEST. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: WILL SEND OUT SOME SETS AND PACKAGING MATERIAL SO CUSTOMER CAN SHIP BACK TO US SHIP: 1 MMT-397 1 LG ENVELOPE 1 LG CANISTER / RETURN: 2 MMT-397.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41263 PARADIGM QUICK SET MMT-397 SET, ADMINISTRATION, INTRAVASCULAR FPA MEDTRONIC MINIMED MMT-397 5108174 20643169442911

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR